Epidemiological Investigation of COVID-19 in Laos Using a One-Health Approach in Human and Animals

NCT04716543 | Unknown

• 1 other identifier: ANRS COV20 LACOVISS
• Study Type: observational
• Target: 5,400
• Locations: 0 countries
• Sites: N/A

Brief Summary

The Respiratory infection COVID-19, due to a new coronavirus, SARS-CoV2, appeared in December 2019 in several people who attended the wildlife market in Wuhan, Hubei Province, China. While COVID-19 has spread to nearly 200 countries and caused two millions infections, Lao PDR detected its first confirmed case very recently, on March 20, three months after the start of the outbreak in China. As of April 12th, 2020, Lao PDR has only recorded 18 confirmed cases, a very low number compared to other countries around the world. However, several key factors suggest that Lao PDR could be much more affected by COVID-19 because of the following reasons: (i) The multiple and massive trans-border movements between Lao PDR and China. (ii) The similar biogeographical and socio-ecological characteristics with South-Western China. (iii) The detection of a high diversity of Betacoronavirus sequences in several species of bats in Lao PDR. (iv) The numerous markets selling high volumes of local wildlife including bats and pangolins. LACOVISS project aim at investigating, using a ONE-HEALTH approach, this unexpected epidemiological pattern of SARS-CoV-2 in Lao PDR by bringing together an interdisciplinary team of experts in the field from IRD, the University of Caen, the Center of Infectiology Lao-Christophe Mérieux (CILM) and the National animal Health Laboratory (NAHL) in Vientiane. The study will focus on a community-based cohort of 1092 households, including 5400 study participants, followed-up between March 2015 and February 2019 for influenza-like illness investigation and causative agents detection (LACORIS project), located in the Vientiane metropolitan area. The COVID-19 progression in Lao PDR, and track SARS-CoV-2, will be followed retrospectively and prospectively, in all potential actors in SARS-CoV-2 circulation, including humans, domestic animals, and wildlife. The LACOVISS project will undoubtedly bring new insight in SARS-Cov-2 and SARS-CoV-like circulation in Lao PDR as well as valuable information on the natural history of COVID-19, and on the modalities of the spillover into humans, which are still largely unknown.

Conditions

Influenza -Like Illness; Covid19

Keywords

SARS-CoV-2; Lao PDR; One Health; virus; coronavirus; reservoir; animal; antibody; serology; PCR

Outcome Measures

Primary Outcomes (1)

• Prevalence of SARS-CoV-2 RNA in respiratory samples collected from influenza-like illness patients from cohort study 2020-2021

  Number of participants SARS-CoV-2 positive among total number of participants tested

  Months 12

Secondary Outcomes (1)

• Prevalence of SARS-CoV-2 RNA in respiratory samples from influenza-like illness patients from cohort study between 2015 and 2019

  Months 12

Other Outcomes (3)

• Prevalence of SARS-CoV-2 RNA in respiratory samples from intrafamilial contacts of influenza-like illness patients (2020-2021)

  Months 12

• Prevalence of SARS-CoV-2 IgG among 1000 individuals randomly selected from the 2020-2121 study cohort. IgG will be assayed in saliva samples

  Months 12

• Prevalence of SARS-CoV-2 RNA in respiratory and faecal samples collected from companion animals living with influenza-like illness patients

  Months 12

Study Arms (1)

ILI Investigation

The suspected ILI cases will be first identified using the WHO clinical case definition of ILI and Covid 19 as either with:Acute onset of fever (\> 37.5˚C axillary temperature or \> 38˚C tympanic temperature) AND cough; OR Acute onset of ANY ONE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anosmia (loss of smell) or ageusia (loss of taste); with symptoms with onset within the last 10 days.

Diagnostic Test: ILI and COVID-19 detection

Interventions

ILI and COVID-19 detection DIAGNOSTIC_TEST

All participants presenting with ILI symptoms will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire. All family members more than 6 months living with SARS-CoV-2 positive individuals will have will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire.

ILI Investigation

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will cover 1092 households, including 5400 study participants living in 25 villages within the administrative boundaries of the Vientiane metropolitan area.

You may qualify if:

• Over a year, active case finding for influenza-like illness (ILI) will be conducted among the cohort by staff at CILM. The suspected ILI cases will be first identified using the WHO clinical case definition of ILI and Covid 19 as either with:
• Acute onset of fever (\> 37.5˚C axillary temperature or \> 38˚C tympanic temperature) AND cough; OR Acute onset of ANY ONE OR MORE of the following signs or symptoms: Fever, cough, general weakness/fatigue, headache, myalgia, sore throat, coryza, dyspnoea, anosmia (loss of smell) or ageusia (loss of taste).
• with symptoms with onset within the last 10 days.
• Living in their respective village for 6 months or more.
• Physically reside in the village for more than 80% of the time during the duration of the study.
• Study subjects ≥ 6 months of age (no upper age limit).
• Consent form signed by patient, or if under 18 years of age or patients with learning difficulty or other vulnerability with impaired ability to decide on consent, signed by parent or guardian.
• Agrees to comply with study requirements.

You may not qualify if:

• Study subjects under the age of 6 months.
• Study subjects or parents/guardians that do not accept participation.
• Study subjects or parents/guardians who refuse to sign informed consent.

Sponsors & Collaborators

• ANRS, Emerging Infectious Diseases: lead
• Institut de Recherche pour le Developpement: collaborator
• Centre d'Infectiologie Charles Mérieux: collaborator
• University Hospital, Caen: collaborator
• Department of livestock and fisheries National animal health laboratory, Vientiane, Laos: collaborator

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Nasal and saliva swabs

MeSH Terms

Conditions

COVID-19; Virus Diseases; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Phimpha PABORIBOUNE, MD, PhD

  Centre d'Infectiologie Lao-Christophe Mérieux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric M LEROY, DVM, PhD

CONTACT

+33 467416107; eric.leroy@ird.fr

Sabrina LOCATELLI, PhD

CONTACT

+33 680596357; sabrina.locatelli@ird.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2020
• First Posted: January 20, 2021
• Study Start: August 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share